A user facility biomedical technician (biomed) reported that a 2008t machine experienced an intermittent flow error flow, and that burn damage was found on the distribution board and the wiring from the distribution board to the power supply.The biomed stated the burn damage consisted of melting and charring.There was no burning smell, smoke, or arcing noted.In addition, there were no reports of sparks or flames.No damage was identified on any other components.The biomed confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.There were approximately 6,800 hours logged on the machine at the time of the event.There was no patient involvement associated with the reported event.The machine remained out of service at the time of follow up, as the biomed was awaiting the arrival of replacement parts.Multiple attempts to obtain resolution information have been performed, and to date, no further details have been provided.It is unknown if parts will be returned for a manufacturer evaluation.
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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